Medical Device Manufacturer · US , Bloomington , IN

Cook Incorporated - FDA 510(k) Cleared Devices

175 submissions · 153 cleared · Since 2006

175

Total

153

Cleared

1

Denied

FDA 510(k) cleared devices by Cook Incorporated General Hospital ✕

8 devices

1-8 of 8

Cleared May 17, 2019

Cook Unimpregnated Central Venous Catheter

General Hospital · 270d

Cleared Feb 22, 2018

Silicone Peripherally Inserted Central Venous Catheter Set/Tray

General Hospital · 234d

Cleared Oct 07, 2016

Turbo-Flo PICC Sets

General Hospital · 128d

Cleared Jul 26, 2016

Cook Intraosseous Infusion Needles

General Hospital · 117d

Cleared May 21, 2015

Vital-Port Vascular Access System Power Injectable Port

General Hospital · 62d

Cleared May 21, 2014

VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM

General Hospital · 118d

Cleared Oct 11, 2013

TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET

General Hospital · 25d

Cleared May 06, 2010

SPECTRUM TURBO-JECT PICC SET

General Hospital · 28d